FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Stent, Iliac
PMA: P940019
·
Supplement: S036
·
Decision Apr 18, 2013
Classifications
1
FEI Numbers
34
Registration Numbers
34
Basic Information
- Device Name
- Stent, Iliac
- Trade Name
- WALLSTENT (ILIAC) ENDOPROSTHESIS
- PMA Number
- P940019
- Supplement Number
- S036
- Device Class
- FDA Class 3
- Product Code
- NIO
- Generic Name
- STENT, ILIAC
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- 30-Day Notice Accepted
- Decision Code
- OK30
- Decision Date
- April 18, 2013
- Date Received
- March 21, 2013
- Supplement Type
- 30-Day Notice
- Expedited Review
- N
Advisory Committee Statement
ELIMINATE AN IN-PROCESS VERIFICATION ACTIVITY.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| NIO | Stent, Iliac | FDA class 3 | Unknown |